Roche launches laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
Basel, 11 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has launched a high-throughput SARS-CoV-2 antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections, in markets accepting the CE Mark. Roche has also filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration.
The Elecsys? SARS-CoV-2 Antigen test is a highly accurate laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS-CoV-2. In clinical studies, the Elecsys SARS-CoV-2 Antigen test showed a 94.5% sensitivity across 200 PCR confirmed symptomatic individuals* and a 99.9% specificity across 2747 PCR negative symptomatic and screening individuals. It is planned to ramp up production to have a double-digit million number of tests per month, in early 2021, depending on the demand of healthcare systems, globally. The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2. A widely available, laboratory-based automated antigen assay allows for cost and error reduction due to removal of manual handling as well as fast turn-around times and high test throughput.
?Healthcare systems remain under significant pressure to deliver robust testing options, with a sufficient number of tests available?, said Thomas Schinecker, CEO Roche Diagnostics. ?The launch of our high-throughput antigen test will provide additional testing capacity to reliably support healthcare systems in diagnosing SARS-CoV-2 infection, as a supplement to PCR testing.?
About the Elecsys SARS-CoV-2 Antigen test
Roche?s Elecsys SARS-CoV-2 Antigen test is an immunoassay intended for the qualitative detection of SARS-CoV-2 present in the respiratory tract including nasopharynx and oropharynx. The Elecsys SARS-CoV-2 Antigen test is performed by healthcare professionals and could be used as an alternative or in conjunction with PCR testing. This is highly beneficial where reliable laboratory PCR testing is limited or not available. A positive result with the Elecsys SARS-CoV-2 Antigen test, In symptomatic individuals, a positive result with the Elecsys SARS-CoV-2 Antigen test,? indicates an active SARS-CoV-2 infection with a likelihood of 94.5%. A negative result may require to be confirmed with a PCR test or repeated (antigen test) after one to two days, if other clinical indications point to a SARS-CoV-2 infection.
The Elecsys SARS-CoV-2 Antigen immunoassay runs on all cobas e immunochemistry analysers which are widely available around the world and allow for these test to be run alongside other COVID-19 infectious diseases diagnostic markers available from Roche, which run on the cobas e systems. These fully automated systems can provide test results in 18 minutes for a single test (excluding time for sample collection, transport, and preparation), with a throughput of up to 300 tests per hour from a single analyser, depending on the analyser.1
About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are thus very specific to that pathogen.2?In this case, the test would provide a qualitative ?yes/no? answer on the presence of the pathogen in the patient sample. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a positive result, indicating an active infection.3
In general, antigen tests have a high specificity, though are not as sensitive as PCR tests that amplify the target viral DNA or RNA sequence in order to generate a quantifiable signal to indicate the presence of the virus in a sample. Therefore, to make up for the potential decrease in sensitivity of an antigen test, negative results should be analysed together with additional patient factors, such as COVID-19 exposure history, clinical symptoms, additional test results to help guide the diagnosis and subsequent treatment of the patient.
About Roche?s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19.? We have developed a growing number of diagnostic solutions that help to detect and diagnose? the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease.
We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future.
Our diagnostics solutions:
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes:
Detection of acute infections (SARS-CoV-2 PCR or Antigen) | Detection of immune response (SARS-CoV-2 Antibodies) | |
Laboratory setting | cobas? SARS-CoV-2 Test cobas? SARS-CoV-2 & Influenza A/B Test NEW: Elecsys? SARS-CoV-2 Antigen Test | Elecsys? Anti-SARS-CoV-2 (N)4?immunoassay Elecsys? Anti-SARS-CoV-2 S5?Immunoassay |
Point of Care setting (near patient) | SARS-CoV-2 Rapid Antigen Test** cobas? Liat? SARS-CoV-2 Test | SARS-CoV-2 Rapid Antibody Test** |
- a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorisation (EUA) and available in countries accepting the CE Mark)
- a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)
- an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19? (FDA EUA and CE Mark)
- Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic
- a SARS-CoV-2 rapid antibody test to help determine at the point of care whether a person has been exposed to the virus (CE Mark)
- a rapid antigen test to support in the detection of SARS-CoV-2 at the point of care within 15 minutes (CE Mark)
- a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
- a second SARS-CoV-2 antibody test, aimed at measuring the spike protein to support vaccination development and complement our existing portfolio
- a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark)
Dr. Nicolas Dunant Phone: +41 61 687 05 17 | Patrick Barth Phone: +41 61 688 44 86 |
Dr. Daniel Grotzky Phone: +41 61 688 31 10 | Karsten Kleine Phone: +41 61 682 28 31 |
Nina M?hlitz Phone: +41 79 327 54 74 | Nathalie Meetz Phone: +41 61 687 43 05 |
Dr. Barbara von Schnurbein Phone: +41 61 687 89 67 |
Roche Investor Relations | |
Dr. Karl Mahler Phone: +41 61 68-78503 e-mail:?karl.mahler@roche.com | Jon Kaspar Bayard Phone: +41 61 68-83894 e-mail:?jon_kaspar.bayard@roche.com |
Dr. Sabine Borngr?ber Phone: +41 61 68-88027 e-mail:?sabine.borngraeber@roche.com | Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail:?bruno.eschli@roche.com |
Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail:?birgit.masjost@roche.com | Dr. Gerard Tobin Phone: +41 61 68-72942 e-mail:?gerard.tobin@roche.com |
Investor Relations North America | |
Loren Kalm Phone: +1 650 225 3217 e-mail:?kalm.loren@gene.com | Dr. Lisa Tuomi Phone: +1 650 467 8737 e-mail:?tuomi.lisa@gene.com |